1. Field of Invention
This invention generally relates to laparoscopic surgery and trocar port placement. More particularly, the invention relates to tissue closure devices, including surgical suturing devices as well as such devices that can be used for intra-abdominal suturing and suturing of puncture wounds generated by surgical laparoscopic trocar ports and other puncturing devices.
2. Prior Art
Apparatus and methods are provided for treating tissue opening, for example an endoscopic trocar port opening used in a minimally invasive surgical procedure. A suture placement device is provided to rapidly, safely, efficiently and effectively close tissue defects created to access the intra-abdominal cavity during laparoscopic surgical procedures in a human body. The device as described is able to obtain adequate tissue adjacent to the tissue defect to provide a strong closure, to maintain pneumoperitoneum needed for appropriate visualization of the peritoneal contents during the closure process, and to protect the vital structures within the abdominal cavity in the vicinity and the healthcare provider for risk of injury.
The prior art discloses various methods of routing and presenting a suture so that suture ends can be tied to close an opening in tissue after a cannular device is removed from the tissue. Representative prior art devices are discussed below and shown in FIGS. 1-6.
FIGS. 1A-1B show a prior art device of U.S. Pat. No. 7,060,077 to Gordon et al. In one embodiment provides needle holders that releasably hold a pair of needles that are in turn attached to each end of a single piece of suture material. Such needle holders are held within tubular guiding tracks housed within a hollow outer sleeve that may be introduced into a puncture wound. The needle holders and guiding tracks may be deployed outside the hollow sleeve to allow the needles to engage the tissue to be approximated. A plunger is coupled to rigid driving members that are in turn attached to flexible driving members adapted to follow the shape of the guiding tracks. The flexible driving members are suitably attached to the needle holders. The plunger is pushed, simultaneously driving the needle pair into opposite sides of the puncture wound and into catches also disposed within the hollow sleeve. The needle holders are retracted into the guiding tracks, and the tracks pulled back into the hollow sleeve trailing the suture material. The device may then be withdrawn, leaving a loop of suture material precisely placed in the selected tissue, for example, in the interior wall of the body cavity. The needles are removed from the ends of the suture, and the suture material is tied to complete the approximation of the tissue.
FIG. 2 is a prior art device described in US Patent Application No. 20120035623 to Bagaoisan et al. In one example, a closure device includes a longitudinally extending body having a proximal portion and a distal portion. The distal portion includes a suture holding portion extending a first distance laterally from a first axial position on the body. The body further includes a substantially straight, suture-receiving passageway extending at an angle to a central axis of a body. The passageway includes an entrance opening and an exit opening on the body distal of the entrance opening and it is substantially aligned with the suture holding portion. The exit opening on the body is positioned proximally at a second axial position relative to the first axial position and spaced therefrom a second distance.
FIG. 3 is a prior art device described in US Patent Application No. 2008/0033459 to 20080033459 to Shafi et al. The physician then uses a needle actuator to drive two diametrically opposed flexible nitinol needles housed in the shaft of the instrument out of the ports on the body of the device. The flexible needles are driven in opposite directions through the tissue layers the physician is interested in closing, towards the distal ends of the pivoting extensions. The flexible needles are driven out at a predetermined height and angle to ensure that an adequate amount of tissue is used to close the tissue defect. The flexible needles need to be flexible enough to be manipulated within the body of the device and driven to an adequate distance away from the body of the device to obtain enough tissue for a strong closure. The flexible needles are also configured to have the appropriate stiffness to pierce through the tissue of interest without buckling. The flexible needles will be driven into the coupling channel to be received in the pivoting extensions by a set of couplers attached to the same suture that would be used otherwise to close the port sites. The distal ends of the flexible needles are configured to mate with the couplers and pull the suture back through the tissue adjacent to the tissue defect. The physician then releases the lock on the pivoting extensions and uses the pivoting extension actuator to bring the pivoting extensions back into profile with the body. The device is then pulled out of the tissue defect, leaving a looped suture through the tissue adjacent to the tissue defect. The physician can then tie the sutures as he or she would normally do in the standard procedure.
FIGS. 4A and 4B are a prior art device shown in U.S. Pat. No. 8,109,943 to Boraiah et al. The patent describes systems and methods for suture anchor deployment. A trocar port system includes a cannula assembly and an obturator assembly, the cannula assembly providing a needle assembly and the obturator assembly providing a needle actuation mechanism. The obturator assembly may be at least partially inserted into the cannula assembly and arranged to operatively couple the needle actuation mechanism to the needle assembly. The needle assembly includes at least one needle, each needle having disposed near its distal tip a suture anchor. A method includes steps for deploying and/or depositing at least one suture anchor in or through an organ of the human body.
FIGS. 5A and 5B are illustrations of a portion of a prior art Neat Stitch™ closure device showing a pair of needle guides which are released from a cartridge and positioned against the bottom of the fascia. The needle guides contain needles (not shown). As the needles are released and forced through the fascia and into the shaft of the device, a pre-loaded suture is routed through the fascia. When the device is removed, the two ends of the suture may be pulled and tied to close the incision.
FIGS. 6A-6B are a prior art device described in US Patent Application No. 2013/0165956 to Sherts et al. The '956 application describes a suture passer guide that includes an elongate member having a longitudinal axis and defining a first proximal opening and a first distal opening. The first proximal and distal openings are substantially aligned with one another such that a suture passer can be extended through the first proximal and distal openings at an acute angle relative to the longitudinal axis of the elongate member. The suture passer guide can be configured to be passed through a central lumen of an endoscopic port.
TAP Block
It is desirable in endoscopic and robotic surgery to perform a TAP block (transverse abdominal plane) and/or to inject an anti-inflammatory agent in proximity to a trocar port in order to provide short term or prolonged post-operative pain relief for a patient.
FIG. 56 is a prior art illustration of a TAP block. In this method, an ultrasound probe is used to determine when a needle tip is in a desired position between internal oblique muscle (IO) and the transversus abdominis (TA) so that a local anasthetic (I) may be injected. This intramuscular region between the internal oblique muscle (IO) and the transversus abdominis (TA) is also the desired injection site for steroids or NSAIDs (non-steroidal anti-inflammatory drugs).
FIG. 57A is a prior art illustration, from above downwards, of skin; subcutaneous tissue; fat; and the external oblique (EO), internal oblique muscle (IO), the transversus abdominis (TA) muscles. The peritoneum and bowel loops may also be visualized deeper to the muscles.
FIG. 57B is a prior art illustration showing the desired positioning of a TAP block between the internal oblique muscle (IO), and the transversus abdominis (TA) muscles. Upon reaching the desired plane with ultrasound guidance, 2 ml of saline is injected to confirm correct needle position, after which 20 ml of local anesthetic solution is injected. The TAP plane is shown expanding with the injection, as indicated by the ultrasound.
In the present invention, an endoscopic trocar port closure device may be configured to inject or otherwise deliver one or more substances at a desired intra-muscular layer.